India likely to have COVID-19 vaccine by December: Adar Poonawalla
What's the story
India should have a vaccine to exit the COVID-19 pandemic by the end of this year. The claim comes directly from Adar Poonawalla, the Chief Executive of Serum Institute of India, the organization racing to mass-manufacture and distribute potential vaccine candidates developed to fight the deadly respiratory disease. Here's all you need to know about it.
Claim
Candidates moving toward trials, should launch by December
In a recent conversation with CNBC-TV18, Poonawalla said that one of their candidate vaccines against COVID-19, the ChAdOx1 nCoV-19 from Oxford University/AstraZeneca, should be available in India by December. "We are going to start trials in less than two weeks...The trial is in partnership with ICMR," Poonawalla said, noting that "We will start manufacturing vaccines by the end of August."
Trials
Trials will have 4,000-5,000 volunteers
The trials in question, as Poonawalla explained, are part of a broader Phase-2/3 study, which has been cleared by Drug Controller General of India and will have 4,000-5,000 local volunteers. They will be given two doses of the vaccine four weeks apart; the resulting data will be correlated with that collected from foreign trials of the shot to confirm safety and efficacy by November.
Funding
Manufacturing being funded by Bill & Melinda Gates Foundation
Poonawalla said they will begin at-risk vaccine manufacturing by the end of August to ensure sufficient supply by the time of approval, distribution. He said that the total cost of manufacturing is $250 million, of which $150 million has been funded by the Bill & Melinda Gates Foundation through GAVI, the vaccine alliance. This way, Serum doesn't have to foot the whole manufacturing bill.
Information
100 million doses for low-income countries by 2021
Under the partnership with Gates Foundation, Serum Institute has agreed to manufacture and deliver up to 100 million COVID-19 vaccine doses for up to 90 low-income countries, including India, by 2021. Poonawalla had previously said the company plans to manufacture 300-400 million doses by year-end.
Pricing
Cost would be around Rs. 250/dose
When announcing the partnership with Gates Foundation, Serum Institute had also said that it will sell the shots at a special price of $3/dose (Rs. 250). However, in the interview, Poonawalla clarified the shot could get a "dollar or two" more expensive than the quoted value after licensing. We will know the final pricing in two months, he added.
Performance
Oxford vaccine has shown promise in early-stage trials
The Oxford vaccine, although not yet approved, has shown promise in early-stage trials by safely generating "dual immunity" in volunteers. The Phase-2/3 data will give the final answer, but if it does not prove effective, Poonawalla says Serum Institute has backup candidates to move forward with. One of these is the shot from American biotech company Novavax.